Guardian Real-Time Monitor — Class II medical device recall Z-2442-2015
Terminated recall by Medtronic MiniMed Inc., reported 2015-09-02. Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a la
| Recall number | Z-2442-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic MiniMed Inc., Northridge, CA, United States |
| Recall initiated | 2015-07-22 |
| Classified | 2015-08-21 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2015-09-18 |
| Countries outside the US | FI |
| Quantity | 254 units |
| Model numbers | CSS7100 |
Product
Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.
Reason for recall
Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish language. Specifically, the Monitor has a Finnish translation error in Predictive Alerts setting: the on-screen Finnish translation for LOW/HIGH is reversed as HIGH/LOW.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2442-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.